QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM
FDA premarket approval P010033/S004 · decided 2003-08-07
Approval details
- PMA number
- P010033
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- Qiagen
- Date received
- 2003-02-28
- Decision date
- 2003-08-07
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- APPROVAL FOR THE USE OF THE QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM FOR USE WITH THE QUANTIFERON-TB TEST. THE DEVICE ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM AND IS INDICATED AS A STAND ALONE PROGRAM FOR ANALYSIS OF RAW EIA DATA AND CALCULATION OF QUANTIFERON-TB ASSAY RESULTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
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| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |